The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial
Abstract Background Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evalua...
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| Format: | Article |
| Language: | English |
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BMC
2020-10-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-020-05507-4 |
| _version_ | 1811223449042944000 |
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| author | Naser Gharebaghi Rahim Nejadrahim Seyed Jalil Mousavi Seyyed-Reza Sadat-Ebrahimi Reza Hajizadeh |
| author_facet | Naser Gharebaghi Rahim Nejadrahim Seyed Jalil Mousavi Seyyed-Reza Sadat-Ebrahimi Reza Hajizadeh |
| author_sort | Naser Gharebaghi |
| collection | DOAJ |
| description | Abstract Background Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection. Methods This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042). Conclusions Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment. Trial registration A study protocol was registered at the Iranian Registry of Clinical Trials ( www.IRCT.ir ), number IRCT20200501047259N1 . It was registered retrospectively on May 17th, 2020. |
| first_indexed | 2024-04-12T08:33:11Z |
| format | Article |
| id | doaj.art-a5b593b0f00143ffbae58210e04aa682 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-04-12T08:33:11Z |
| publishDate | 2020-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-a5b593b0f00143ffbae58210e04aa6822022-12-22T03:40:07ZengBMCBMC Infectious Diseases1471-23342020-10-012011810.1186/s12879-020-05507-4The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trialNaser Gharebaghi0Rahim Nejadrahim1Seyed Jalil Mousavi2Seyyed-Reza Sadat-Ebrahimi3Reza Hajizadeh4Department of Infectious Diseases, Urmia University of Medical SciencesDepartment of Infectious Diseases, Urmia University of Medical SciencesDepartment of Infectious Diseases, Urmia University of Medical SciencesCardiovascular Research Center, Tabriz University of Medical SciencesDepartment of Cardiology, Urmia University of Medical SciencesAbstract Background Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection. Methods This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042). Conclusions Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment. Trial registration A study protocol was registered at the Iranian Registry of Clinical Trials ( www.IRCT.ir ), number IRCT20200501047259N1 . It was registered retrospectively on May 17th, 2020.http://link.springer.com/article/10.1186/s12879-020-05507-4Coronavirus disease 2019COVID-19SARS-CoV-2Severe infectionIntravenous immunoglobulin |
| spellingShingle | Naser Gharebaghi Rahim Nejadrahim Seyed Jalil Mousavi Seyyed-Reza Sadat-Ebrahimi Reza Hajizadeh The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial BMC Infectious Diseases Coronavirus disease 2019 COVID-19 SARS-CoV-2 Severe infection Intravenous immunoglobulin |
| title | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial |
| title_full | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial |
| title_fullStr | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial |
| title_full_unstemmed | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial |
| title_short | The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial |
| title_sort | use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019 a randomized placebo controlled double blind clinical trial |
| topic | Coronavirus disease 2019 COVID-19 SARS-CoV-2 Severe infection Intravenous immunoglobulin |
| url | http://link.springer.com/article/10.1186/s12879-020-05507-4 |
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